Cognitive Behavioral Group Therapy for the Management of Menopause Symptoms in Mood Disorders

Not Applicable

Completed

• Conditions: Menopause; Bipolar Disorder; Major Depressive Disorder
• Interventions: Behavioral: Cognitive Behavioral Group Therapy

• Registration Number: NCT02860910
• Lead Sponsor: Danette Conklin, PhD

Brief Summary

The general objective of this study is to advance insight into non-pharmacological treatments for maturing women that impact psychological health and wellbeing of women adapting to menopause, a natural but often challenging developmental milestone.

Detailed Description

This exploratory study proposes to expand the knowledge in the menopausal literature and evaluate the effectiveness of cognitive-behavioral group therapy (CBGT) in reducing problematic vasomotor symptoms, reducing daily interference and improving quality of life. The study will include two homogenous peri- or post-menopausal cohorts (African-American and Caucasian) with major depressive disorder or bipolar disorder. The intervention will be delivered in groups of 6 to 10 participants per group of both race/ethnicities in an outpatient setting during a 6-week time period. The participants will be assessed on the degree of hot flash problem rating, hot flash related daily interference, and menopause quality of life at screening, baseline, and post-treatment. Participants will also be assessed using the following predictor variables at the same time points: body mass index (BMI), level of perceived stress, severity of depression, severity of anxiety level of pleasure, severity of mania, hot flash beliefs and severity of couple's conflict.

Study Timeline

• Study First Submitted: 2016-06-14
• Study Start: 2016-07
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Group Therapy	Cognitive Behavioral Group Therapy	The six CBGT sessions are outlined in the manual entitled: Managing Hot Flushes with Group Cognitive Behaviour Therapy: An Evidenced-Based Treatment Manual for Health Care Professionals (Hunter \& Smith, 2015) as follows: Session 1: Psycho-education and the cognitive behavioural model Session 2: Stress management, improving wellbeing and identifying precipitants Session 3: Managing hot flushes using a cognitive behavioural approach Session 4: Managing night sweats and improving sleep (part one) Session 5: Managing night sweats and improving sleep (part two) Session 6: Review and maintaining changes (One alteration: Open discussion about mood disorders, anxiety and the psychological impact instead of the psychological impact of breast cancer)

Primary Outcome Measures

Name	Time	Method
Number of participants who begin cognitive group behavioral therapy	2 years
Change in Hot Flush Rating Scale: Frequency and Problem Rating (HFRS) total score	Baseline and Week 6

Secondary Outcome Measures

Name	Time	Method
Change in Menopause Representation Questionnaire (MRQ) total score	Baseline and Week 6
Change in Hot Flash Daily Interference Scale (HFRDIS) total score	Baseline and Week 6

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center - Mood Disorders Program; 🇺🇸 Cleveland, Ohio, United States